Registration Dossier
Registration Dossier
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EC number: 273-967-1 | CAS number: 69322-01-6
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: following the Journal Officiel de la République Française of 21/1/71 and 8/6/73
- Principles of method if other than guideline:
- The method is similar to OECD guidelines, but the exposure is under occlusive patch and and duration is 24 hours.
- GLP compliance:
- no
Test material
- Reference substance name:
- 4-hydroxyphenylglycolic acid
- EC Number:
- 214-839-7
- EC Name:
- 4-hydroxyphenylglycolic acid
- Cas Number:
- 1198-84-1
- Molecular formula:
- C8H8O4
- IUPAC Name:
- hydroxy(4-hydroxyphenyl)acetic acid
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Centre d'Elevage Charles River France (76410 Saint Aubin les Elbeuf)
- Age at study initiation: no data
- Weight at study initiation: between 2.5 and 2.5 kg
- Housing:kept in individual in cages measuring 0.35x0.55x0.32m.
- Diet: reference 112, U.A.R., 91360 Villemoisson-sur-Orge)
- Water: ad libitum
- Acclimation period: at least 8 days
ENVIRONMENTAL CONDITIONS
- Temperature: 18°C ± 1°C
- Humidity: 50% ± 5%
- Air changes: 8 times per hour
- Photoperiod: 12 hrs dark / 12 hrs light
IN-LIFE DATES: no data
Test system
- Type of coverage:
- not specified
- Preparation of test site:
- not specified
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 g moistened with water - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 72 hours
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: flanks (scarifed and not scarified)
- % coverage: no data
- Type of wrap if used: impregnated gauze.
REMOVAL OF TEST SUBSTANCE
- Washing: no data
OBSERVATION TIME POINTS
24 and 72 hours
SCORING SYSTEM:
- Method of calculation: as in the guideline
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- scarified
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 24 h
- Score:
- 0.17
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hrs
- Irritation parameter:
- edema score
- Remarks:
- scarified
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Remarks:
- non scarified
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0.17
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hrs
- Irritation parameter:
- edema score
- Remarks:
- non scarified
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Remarks:
- scarified
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- scarified
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Remarks:
- non scarified
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- non scarified
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Remarks:
- scarified or not
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 24/48/72 h
- Score:
- < 0.1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hrs
- Irritation parameter:
- edema score
- Remarks:
- scarified or not
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Other effects:
- no mortality or clinical signs observed
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this study in rabbits, the substance is considered as non irritant after a 24-hour exposure.
- Executive summary:
In a primary dermal irritation study, NZW rabbits (6 males) were dermally exposed to 0.5 g of 4-Hydroxyphenylglycolic acid (moistened with water) for 24 hours (on both flanks, one was abraded). Animals then were observed for 3 days. Irritation was scored by the method of Draize.
One animal showed an erythema with a score=1 at 24 hours, all other scores are "0".
Thus 4-Hydroxyphenylglycolic acid is considered as non irritant according to CLP criteria.
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